According to the National Institute of Allergy and Infectious Diseases (NIAID), AstraZeneca on Tuesday, according to the National Institute of Allergy and Infectious Diseases (NIAID), gave an incomplete review of the efficacy data regarding its COVID-19 vaccine clinical trials.
The British pharmaceutical company said in a statement early Monday that the Phase III trial of its COVID-19 vaccine – which was carried out in the US – shows an effectiveness of 79% in preventing symptomatic infections and a 100% effectiveness in preventing serious diseases. and hospitalization. ‘
Later on Monday, the Data and Security Monitoring Board [DSMB] notified AstraZeneca, NIAID and the Biomedical Advanced Research and Development Authority [BARDA] that the company is concerned about information that the company disclosed about the initial data from its clinical trial with the COVID-19 vaccine, the NIAID wrote in a statement.
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A police officer receives an injection of AstraZeneca’s COVID-19 vaccine in Munich, Germany, on March 2, 2021. (Sven Hoppe / dpa via AP, File)
“The DSMB has expressed its concern that AstraZeneca may have included outdated information from the trial, which may have given an incomplete overview of the effectiveness data,” the statement said. “We call on the company to work with the DSMB to review the efficiency data and ensure that the most accurate, most recent efficiency data is released as soon as possible.”
AstraZeneca did not immediately respond to a late-night request for comment from Fox News.
The request to review the efficacy data comes as the company plans to seek US emergency use authorization for the vaccine in the coming weeks.
Authorization and guidelines for the use of the vaccine in the US will be determined by the Food and Drug Administration [FDA] and Centers for Disease Control and Prevention [CDC] after a “thorough review of the data by independent advisory committees,” according to the statement.
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AstraZeneca US President Ruud Dobber said this week that the company will be able to provide 30 million doses to Americans once the vaccine has been cleared for emergency use.
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Dobber recently tried to assure the American public that the company’s COVID-19 vaccine is safe, despite concerns about the link with possible blood clots emerging in Europe.
Fox News ‘Edmund DeMarche and Fox Business’ Brittany De Lea contributed to this report